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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05141838
Other study ID # 307308294
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 21, 2020
Est. completion date January 2023

Study information

Verified date December 2021
Source National Medical Research Center for Children's Health, Russian Federation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This retrospective prospective study is aimed at studying the level of vitamin D supply and identifying markers of bone tissue remodeling in order to develop approaches to the prevention of osteopenia and osteoporosis in children with congenital epidermolysis bullosa.


Description:

This retrospective prospective interventional study will examine vitamin D availability and its relationship with clinical disease, patient gender and age, and season. The mechanisms of impairment of phosphorus-calcium metabolism and bone tissue metabolism will be analyzed on the basis of biochemical parameters and instrumental research methods in children with dystrophic epidermolysis bullosa in order to develop personalized approaches for correcting vitamin D status and bone metabolism disorders in children with epidermolysis bullosa, followed by an assessment of their clinical efficacy.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date January 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria: - Verified diagnosis of epidermolysis bullosa; - Signing by parents (legal representatives) of informed consent to participate in the study and fulfill the requirements of the study Exclusion Criteria: - not planned

Study Design


Intervention

Drug:
Vitamin D
Adding vitamin D preparations to the therapy in the individual required dosage to correct the deficient state
Dietary Supplement:
Oral nutritional supplement
Adding ?ral nutritional supplement to the therapy depending on the degree of protein-energy malnutrition

Locations

Country Name City State
Russian Federation National Medical Research Center for Children's Health Moscow

Sponsors (1)

Lead Sponsor Collaborator
National Medical Research Center for Children's Health, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vitamin D level Study of the provision of vitamin D in children with dystrophic and simple forms of epidermolysis bullosa based on the level of 25 (OH) vitamin D (25 hydroxycholecalciferol) in the blood Baseline
Primary Vitamin D level Study of the provision of vitamin D in children with dystrophic and simple forms of epidermolysis bullosa based on the level of 25 (OH) vitamin D (25 hydroxycholecalciferol) in the blood 24 week
Primary Phosphorus-calcium metabolism assessment Study of levels of calcium, phosphorus, parathyroid hormone, creatinine, magnesium, albumin in the blood Baseline
Primary Phosphorus-calcium metabolism assessment Study of levels of calcium, phosphorus, parathyroid hormone, creatinine, magnesium, albumin in the blood 24 week
Primary Assessment of the state of bone tissue Study of levels of alkaline phosphatase, osteocalcin, b-CrossLaps, P1NP in the blood Baseline
Primary Assessment of the state of bone tissue Study of levels of alkaline phosphatase, osteocalcin, b-CrossLaps, P1NP in the blood 24 week
Primary Assessment of indicators of physical development Z-score calculation (weight-for-height z-score) Baseline
Primary Assessment of indicators of physical development Z-score calculation (weight-for-height z-score) 24 wee
Secondary Assessment of bone mineral density dual-energy X-ray densitometry Baseline
Secondary Assessment of bone mineral density dual-energy X-ray densitometry 24 week
Secondary Bone age assessment X-ray of the bones of the hand with an assessment of bone age Baseline
Secondary Bone age assessment X-ray of the bones of the hand with an assessment of bone age 24 week
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